MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC FUSION 8MM-80CM SUPP PERIPHERAL GRAFT; VASCULAR GRAFT

Model Number M002015030880

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 04/07/2014

Event Type  Death  

Event Description

The hospital reported a post-operative infection with a pt having surgery with the fusion 8mm-8cm supp peripheral graft.It was reported that there was excessive bleeding from the infected area after the surgery.Date of initial surgery was (b)(6) 2014 infecting agent: staphylococcus aureus.Primary disease: arteriosclerosis obliterans caused by left superficial femoral artery stenosis fontaine "is not equal to u" on (b)(6) 2014, the patient was hospitalized and antibiotics were administered.On (b)(6) 2014, the vascular graft was removed, svg patch was created.On (b)(6) 2014, excessive bleeding was noted from the surgical wound site in the groin.The surgeon incised the surgical wound again and stopped bleeding.On (b)(6) 2014, rebleeding occurred from the groin.Another surgery was done to conduct bypass surgery of external iliac artery, deep femoral artery and superficial femoral artery by svg y-graft.On (b)(6) 2014 rebleeding occurred from the svg, which was not the anastomosis site.The surgeon thought that the svg was infected.On (b)(6) 2014, rebleeding occurred and astriction was conducted.The patient expired on (b)(6) 2014.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical eval cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.A lot history record review was completed for the reported product lot number.There was no non conformance recorded in the lot history.(b)(4).

• Brand Name: FUSION 8MM-80CM SUPP PERIPHERAL GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 3812341
• MDR Text Key: 4404659
• Report Number: 2242352-2014-00508
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: M002015030880
• Device Lot Number: 25085577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death